Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)
NCT ID: NCT01793376
Last Updated: 2019-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2013-02-28
2016-06-30
Brief Summary
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The SB (small bowel) CD (Crohn's Disease)Niv score (CECDAI) is an established and validated CD score for SB involvement. In order to expand this score to the colon, this study will aim to develop the colonic score and later on will be combined with the already established SB score in order to achieve a full CE gut score for Crohn's disease Proposed Design This is a retrospective study in which up to 30 videos of colon Crohn's disease subjects who have undergone the Colon 2 CE procedure will be evaluated.
These cases will have evidence of large and / or small bowel Crohn's disease The chosen videos will be marked for CD lesions by the site The de-identified marked videos will be scored by 4 independent experienced endoscopists, blinded to the results of the standard workup procedures, according to the colonic and CECDAIic new scores
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Yaron Niv, Prof.
Role: PRINCIPAL_INVESTIGATOR
Rabin MC
Other Identifiers
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MA-208-1
Identifier Type: -
Identifier Source: org_study_id
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